Teresa Montagut
Head of Clinical Development & Medical Affairs Mesoblast Ltd.
Teresa Montagut is the Clinical Development & Medical Affairs Head at Mesoblast Ltd., a company at the forefront of allogeneic mesenchymal stromal cell therapy. With Mesoblast’s FDA-approved product sourced from bone marrow, Teresa is an expert in robust donor screening, cell qualification, and potency assays. She champions the importance of validated processes and pre-qualified automation for scaling cell production to meet commercial demands. Teresa is passionate about advancing cell therapy manufacturing to industrial levels, particularly for adherent cells, and seeks to collaborate with vendors offering regulatory-compliant, innovative automation solutions.
Seminars
Tuesday 8th December 2026
Establishing Robust Potency Assays to Overcome Donor Variability & Deliver Consistent Global Cell Therapy Products
2:15 pm
- Qualifying donors, reagents, manufacturing processes and in vitro assays to build FDA-approved potency assays that ensure consistent product release across batches
- Leveraging 10 years of clinical correlations and potency assay development to demonstrate safety, efficacy and reproducible performance independent of donor variability
- Implementing globally reproducible potency testing frameworks to support regulatory approval, commercial scalability and manufacturing consistency across international sites
